Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)

NCT05942339 | Recruiting DMC

• 1 other identifier: BOX2023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or similar studies conducted abroad. They will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system. The goal is to improve more effective lower-limb motor activities, while also simplifying the personal at-home use of the system. In addition, this study aims to evaluate the potential effect of ARC Therapy on muscle tone, bladder, bowel and sexual functions, and quality of life of the participants. Preliminary safety and efficacy will be assessed in both the short term and throughout the duration of the study (from the surgery to 36 months after the implantation of the ARC-IM Lumbar system).

Conditions

Spinal Cord Injuries

Keywords

SCI; Spinal Cord Injury; Epidural Spinal Stimulation

Outcome Measures

Primary Outcomes (1)

• Preliminary safety of the ARC Therapy

  Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM system.

  Through study completion (expected 3 years)

Secondary Outcomes (9)

• 10 Meters Walk test (m/s)

  Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

• 6 Minutes Walk test (meters)

  Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

• International Standards For Neurological Classification of Spinal Injury (ISNCSCI)

  Baseline, 12 months, 24 months and 36 months

• Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

  Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

• Neuromuscular Recovery Scale (NRS)

  Baseline, Short-term (up to 6months), 12 months, 24 months and 36 months

Study Arms (1)

Targeted Epidural Spinal Stimulation

EXPERIMENTAL

Single arm study: the participants who have previously received a spinal array and an implantable pulse generator either through the STIMO study or similar studies conducted abroad will be proposed to exchange their currently implanted system with selected components from the ARC-IM Lumbar system. After the surgery, the participants will perform around 20 optimization sessions that may include rehabilitation to configure the neuromodulation system. Then the participants will use the ARC-IM Lumbar system independently during daily life activities until the end of the 36 months post-surgery. Assessments will be planned throughout the course of the study at the end of the optimization phase, after 12 and 24 months post-surgery and at the end of the study, with and/or stimulation.

Device: Procedure/Surgery

Interventions

Procedure/Surgery DEVICE

The intervention involves the replacement of parts of the current implanted system with components of the ARC-IM Lumbar system.

Targeted Epidural Spinal Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
• Age 18-65
• SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D
• SCI ≥ 12months
• SCI lesion level T10 and above with preservation of conus function
• SCI due to trauma
• Stable medical, physical and psychological condition as considered by the investigators
• Able to understand and interact with the study team in French or English
• Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
• Must provide and sign the Informed Consent prior to any study-related procedures

You may not qualify if:

• Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
• History of myocardial infarction or cerebrovascular event within the past 6 months
• Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
• Any active implanted cardiac device such as pacemaker or defibrillator
• Any indication that would require diathermy
• Any indication that would require MRI
• Any anatomical limitations in the implantation area as judged by the investigators
• Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
• Clinically significant mental illness in the judgement of the investigators
• Presence of indwelling baclofen or insulin pump
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
• Enrolment of the investigator, his/her family members, employees, and other dependent persons
• Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jocelyne Bloch, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégoire Courtine, Prof

CONTACT

+41 21 69 30762; gregoire.courtine@epfl.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurosurgeon

Model Details: Single-site, single-arm, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 12, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)